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MaximaTek

<div>
 
 
 About the Company
 
 
 
 We are seeking a detail-oriented and motivated Clinical Research Coordinator (CRC) to support the planning, execution, and management of clinical trials. This role is ideal for candidates with foundational to intermediate experience in clinical research who are looking to grow their careers in a fast-paced, compliance-driven environment. The CRC will work closely with investigators, sponsors, and study participants to ensure trials are conducted ethically, efficiently, and in accordance with regulatory guidelines.
 
 
 
 
 
 
 About the Role
 
 
 
 This role is ideal for candidates with foundational to intermediate experience in clinical research who are looking to grow their careers in a fast-paced, compliance-driven environment.
 
 
 
 
 
 
 Responsibilities
 
 
 <ul>
 <li>
 Coordinate and manage day-to-day clinical trial activities from study start-up to close-out
 </li>
 <li>
 Screen, recruit, and enroll study participants according to protocol criteria
 </li>
 <li>
 Obtain informed consent and ensure participant understanding of study procedures
 </li>
 <li>
 Schedule and conduct study visits, including data and sample collection
 </li>
 <li>
 Maintain accurate and up-to-date study documentation, including source documents and case report forms (CRFs)
 </li>
 <li>
 Ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and institutional policies
 </li>
 <li>
 Communicate effectively with investigators, sponsors, and clinical trial stakeholders
 </li>
 <li>
 Track and report adverse events and protocol deviations
 </li>
 <li>
 Assist with monitoring visits, audits, and regulatory inspections
 </li>
 <li>
 Manage study supplies, investigational products, and lab samples
 </li>
 <li>
 Support Institutional Review Board (IRB)/Ethics Committee submissions and correspondence
 </li>
 </ul>
 
 
 
 
 
 Qualifications
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field
 </li>
 </ul>
 
 
 
 
 
 Required Skills
 
 
 <ul>
 <li>
 Knowledge of clinical trial processes and regulatory requirements (GCP, ICH guidelines)
 </li>
 <li>
 Strong organizational and time management skills
 </li>
 <li>
 Attention to detail and accuracy in documentation
 </li>
 <li>
 Excellent interpersonal and communication skills
 </li>
 <li>
 Ability to work independently and as part of a multidisciplinary team
 </li>
 <li>
 Proficiency in Microsoft Office and clinical trial management systems (CTMS) or electronic data capture (EDC) systems
 </li>
 </ul>
 
 
 
 
 
 Preferred Skills
 
 
 <ul>
 <li>
 Certification such as ACRP-CP, CCRC, or equivalent
 </li>
 <li>
 Experience with multiple therapeutic areas or phases of clinical trials
 </li>
 <li>
 Familiarity with regulatory submissions and audit processes
 </li>
 </ul>
 
 
 
 
 Ready to Take the Next Step? Email your updated resume to: shivani@maximatek.com
 
 
 
</div>

Clinical Research Coordinator

Danielian Associates Architects + Planners

ADMINISTRATIVE &amp; CONTRACTS ASSISTANTDanielian Associates, an international award-winning global architecture and planning firm, is looking for a Contract &amp; Accounting Administrator to join our team in Irvine, CA. Our firm embraces a work-life balance along with a positive, empowering work environment and culture. As our Contract &amp; Accounting Administrator you will work with the CFO, Accounting and Administrative staff, as well as Project Management and Business Development teams, to skillfully execute and take ownership of the following responsibilities:Job ResponsibilitiesContracts:<ul><li>Coordinate with Principals, Project Managers, and Business Development team to prepare, edit, and finalize all forms of client proposals, contracts &amp; subconsultant agreements.</li><li>Create and update contract templates.</li><li>File management utilizing MS File Explorer, Deltek Vantagepoint (ERP), &amp; DocuSign.</li><li>Input of contract terms into ERP software, including coordination with Accounting staff on setup of billing terms, contract fees, additional services requests (ASR), and budgets.</li><li>Setup new projects, phases &amp; ASR&rsquo;s in ERP software.</li><li>Client &amp; Vendor setups, including individual contacts, W-9 requests, and Certificates of Insurance.</li><li>Project close-outs.</li></ul>Accounting: <ul><li>Assist and backup for basic accounting duties and data entry utilizing accounting software.</li><li>Check Deposits: Run through bank remote deposit system.</li><li>Company Credit Cards: Reconcile monthly statements, collect receipts, enter into Cash Disbursements, prepare for online payment.</li><li>Employee Expense Reports: Coordinate with staff for submission, review, and approval in ERP system.</li></ul>Human Resources Administration:<ul><li>Assist CFO with implementation of Benefits insurance, including changes in enrollments.</li><li>Update payroll withholding for benefits related items, including coordination with broker team.</li></ul>Project Coordination:<ul><li>Assist with project reporting, budgets, and provide support to Principals and Project Managers.</li></ul>Additional Duties: <ul><li>Assist with ad hoc projects, reports, and presentations.</li><li>Provide overall administrative assistance as needed.</li></ul>Qualifications<ul><li>Understanding &amp; experience with contracts, including legal and insurance terms.</li></ul>-Strong capabilities in Microsoft Office, particularly Word, Outlook and Excel.-Outstanding organizational skills.-Experience working with ERP or accounting software, preferably Deltek Vantagepoint.<ul><li>Minimum 1-3 years relevant contracts/accounting/office experience.</li><li>Experience in a professional services firm.</li><li>Superior attention to detail.</li><li>Ability to successfully work alone and in teams.</li><li>Impeccable ethics and character.</li><li>Positive, can-do attitude, quick learner.</li><li>Self-motivated to add value to the organization.</li><li>Strong verbal and written communication skills.</li><li>A true team player excited to contribute to a great company culture!</li></ul>A REAL PLUS<ul><li>Experience using Deltek Vantagepoint &ndash; though we are willing to train.</li><li>Experience using Zoho CRM software &ndash; also willing to train.</li></ul>Compensation Scale<ul><li>$55,000 - $65,000 per year, based on experience and qualifications.</li><li>Assumes full-time employment (40 hours/week), located in Irvine Office.</li><li>Plus annual discretionary bonus.</li><li>Medical/dental/vision benefits.</li><li>PTO</li></ul>If you are a positive person with a can-do attitude and love to work in a team environment, we want to talk to you!DA maintains a strong company culture and was recognized as one of California&rsquo;s Best Workplaces in 2025. As a family-owned business for over 58 years, we strive for EXCELLENCE as a foundation of our core values which includes INGENUITY, INTEGRITY, PASSION, COLLABORATION, and RESPONSIVENESS. If you share these core values and want to be involved in extraordinary design services and projects around the world, we want to speak with YOU.Please send resume and cover letter to: info@danielian.com Subject header: Contract &amp; Administration AssistantPay: $55,000.00 - $65,000.00 per yearBenefits:<ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

ADMINISTRATIVE & CONTRACTS ASSISTANT

The Irvine Company

<div><div><div><div><h2 class="jobSectionHeader">Position Summary:</h2></div><div>
Performs a broad range of duties for a Senior Vice President and their team in the Apartments Division. Responsible for scheduling and preparing agenda for regular and special meetings, for securing requested information and for compiling various reports. Manages appointment requests and maintains assigned calendars. Handles telephone calls, routing them to others or dealing with them directly, as appropriate; arranges conference calls and related meeting room set-up. Prepares a variety of communications including emails, memos, meeting agendas and meeting minutes. Processes expense reports and approves invoices. Monitors budgets for expense and office supply spending.</div></div><div><div><h2 class="jobSectionHeader">
Key Responsibilities:</h2></div><div><ul><li>
Provide administrative support and coordination on projects as assigned.</li><li>
Coordinate and schedule meetings, maintain calendars, and answer calls as assigned.</li><li>
Distribute and track documents, ensure proper routing/approvals, and deliver or file when finalized.</li><li>
Audit and prepare expense reports and check requests and route for approval.</li><li>
Prepare presentations, meeting agendas, letters and other written communications.</li><li>
Administer, organize and maintain project files, hard copy and electronically.</li><li>
Facilitate in setting up conference calls (e.g., video, or telephone, or other electronic variations) and arranging all necessary meeting supplies (i.e. meeting agenda, exhibits, and lunch orders).</li><li>
May book travel as needed.</li><li>
Attend project meetings and prepare meeting minutes as needed.</li><li>
Perform other related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Additional Skills:</h2></div></div><div></div><div><div><h2 class="jobSectionHeader">
Preferred Education:</h2></div><div><ul><li>
Bachelor&rsquo;s Degree (or equivalent experience)</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Preferred Years of Relevant Work Experience:</h2></div><div><ul><li>
3 - 5+ years</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Additional Requirements:</h2></div><div><ul><li>
Strong proficiency with Google products (Mail, Drive, Calendar, Meets, Google Docs, Slides, Sheets), Microsoft products (Word, Excel, Powerpoint) and Adobe</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Minimum Qualifications / Other Expectations:</h2></div><div><ul><li>
Must be organized and capable of managing tasks on multiple, concurrent projects.</li><li>
Must have excellent verbal and written communication skills.</li><li>
Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.</li><li>
Project a professional image and demeanor.</li><li>
Understand, apply, and comply with all company policies and procedures.</li><li>
Strong computer skills: MS Office Office Suite; Google Suite experience preferred.</li></ul></div></div></div>
Compensation:
Base Pay Range: $34.52 - $42.60 
Actual placement within this range may vary based upon, but not limited to, relevant experience, time in role, base salary of internal peers, prior performance, business sector, and geographic location.
The Company also offers competitive benefits for full time employees including paid time off, matching 401(k), and health benefits. 
About Us: 
Irvine Company Apartment Communities (a division of Irvine Company) offers a portfolio of more than 125 resort-style apartment communities in coastal California&rsquo;s most desirable locations: San Diego, Orange County, West Los Angeles and Silicon Valley. 
 
With world-class amenities, resort-like surroundings and an unparalleled commitment to customer service, Irvine Company Apartment Communities redefines the rental-living experience. 
 
We take as much pride in our employee community as we do the communities we create. It&rsquo;s an environment populated with talented and experienced people, a collaborative spirit and abundant opportunities.
Apply today to join our employee community, and learn more about Irvine Company, our legacy and our guiding principles. 
The Irvine Company is committed to providing equal opportunity in all of our employment practices, including selection, hiring, promotion, transfer, compensation, termination, and training, without regard to race, religion, color, sex, sexual orientation, gender, gender identity, national origin, ancestry, citizenship status, marital status, pregnancy, age, medical condition, genetic information, military and veteran status, disability, or any other basis protected by federal, state, and local law. Reasonable accommodation is available for qualified individuals with disabilities, upon request.
#LI-Onsite</div>

Sr. Administrative Assistant ($34.52 - $42.60)

A Tiempo Payroll & Accounting

Job Summary We are seeking for Bilingual Spanish / English. Energetic and highly organized Personal Assistant to provide comprehensive marketing support to our executive team. This vital role involves managing schedules, create alliances, coordinating projects &amp; social media content, handling correspondence, and ensuring smooth office operations. The ideal candidate will demonstrate exceptional organizational skills, proactive problem-solving abilities, and a positive attitude to help our leadership stay focused and efficient. This paid position offers a dynamic environment where your multitasking skills and attention to detail will shine, contributing directly to the success of our organization.Duties<ul><li>Manage and maintain executive calendars using Microsoft Outlook Calendar and Google Workspace, scheduling appointments, meetings, and events with precision.</li><li>Coordinate travel arrangements, including booking flights, accommodations, transportation, and preparing detailed itineraries.</li><li>Manage social media content</li><li>Handle incoming calls with professionalism using multi-line phone systems and uphold excellent phone etiquette.</li><li>Prepare, proofread, and transcribe documents, reports, emails, and correspondence with accuracy and clarity.</li><li>Organize files, maintain records, and oversee filing systems both physically and digitally for easy retrieval.</li><li>Assist with event planning by organizing logistics, preparing materials, and coordinating vendors or participants for company events or meetings.</li><li>Support bookkeeping tasks using QuickBooks for expense tracking and basic financial recordkeeping.</li><li>Perform data entry tasks with high accuracy while managing confidential information discreetly.</li><li>Provide executive administrative support including project coordination, office management duties, and clerical assistance as needed.</li><li>Utilize Microsoft Office Suite (Word, Excel, PowerPoint) to create reports, presentations, and spreadsheets that meet professional standards.</li><li>Manage and coordinate the maintenance services for the 2 locations</li></ul>Qualifications<ul><li>Proven experience as a Personal Assistant or in an administrative support role with a strong background in office management.</li><li>Demonstrated expertise in event planning, project coordination, bookkeeping (QuickBooks preferred), and calendar management.</li><li>Excellent computer literacy with proficiency in Microsoft Office (Word, Excel, PowerPoint), Google Workspace applications, and data entry software.</li><li>Strong organizational skills with keen attention to detail; ability to prioritize tasks effectively in a fast-paced environment.</li><li>Exceptional communication skills with polished phone etiquette and professional demeanor at all times.</li><li>Experience handling transcription, proofreading, filing systems, and office procedures such as front desk responsibilities or clerical tasks.</li><li>Ability to manage multi-line phone systems efficiently while providing outstanding customer service.</li><li>Experience and managing social media platforms</li><li>Familiarity with DocuSign for electronic signatures and basic knowledge of office equipment such as printers and scanners is a plus. This role is perfect for a proactive individual eager to contribute to a vibrant team by ensuring seamless daily operations while supporting our leadership&rsquo;s strategic initiatives. If you thrive in an energetic environment where your organizational talents can flourish&mdash;this opportunity is designed for you!</li><li>This position requires to be bilingual Spanish / English</li></ul>Pay: $19.00 - $22.00 per hourExpected hours: 40.0 per weekBenefits:<ul><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li></ul>Work Location: In person

Brand Ambassador

Full Service CPA Firm

Job Summary We are seeking a dynamic and highly organized Executive Administrative Assistant with a clear growth trajectory toward an Operations Manager role. This vital position offers an exciting opportunity to support executive leadership while developing essential skills in office management, project coordination, and business operations. The ideal candidate will thrive in a fast-paced environment, demonstrating exceptional multitasking abilities, strong communication skills, and a proactive approach to administrative support. This paid position provides a comprehensive pathway for professional growth within our organization, empowering you to transition seamlessly into operational leadership.Duties<ul><li>Provide comprehensive executive administrative support, including calendar management, scheduling meetings, and coordinating appointments using tools like Microsoft Outlook Calendar and Google Workspace.</li><li>Manage multi-line phone systems with professionalism and courtesy, ensuring excellent phone etiquette and customer service at all times.</li><li>Assist with event planning for company meetings, workshops, and community outreach initiatives, handling logistics from venue booking to materials preparation.</li><li>Oversee office management tasks such as filing, data entry, record keeping, and maintaining organized digital and physical files.</li><li>Support bookkeeping and basic accounting functions using QuickBooks, including invoicing,</li><li>Coordinate projects across departments by tracking deadlines, preparing reports, proofreading documents, and ensuring timely completion of tasks.</li><li>Perform transcription and proofreading of business documents, correspondence, and presentations to ensure accuracy and professionalism.</li><li>Handle personal assistant responsibilities for executives as needed&mdash;such as travel arrangements or personal errands&mdash;while maintaining discretion.</li></ul>Requirements<ul><li>Provenat least three experience in a publice accounitng or professional service oreineted firm in the administrative roles with strong organizational skills and attention to detail.</li><li>Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Google Workspace applications, and data entry systems. familarity or some experience in Karbon practice managment software would be a BIG plus.</li><li>Familiarity with QuickBooks for bookkeeping tasks and DocuSign for electronic signatures.</li><li>Excellent typing speed combined with transcription and proofreading capabilities.</li><li>Strong office management skills including filing systems, front desk duties, and multi-line phone operation.</li><li>Exceptional communication skills with professional phone etiquette and customer service orientation.</li><li>Ability to manage calendars efficiently using Microsoft Outlook Calendar or similar tools; experience with project coordination is a plus.</li><li>Demonstrated ability to handle multiple priorities simultaneously while maintaining accuracy under pressure.</li></ul>Team Coordination<ul><li>Coordinate and manage workflow with the existing administrative team of 8 members, including 4 virtual staff and 4 local team members</li><li>Work closely with 28 accounting and tax associates at various levels to ensure smooth communication and task execution across the firm</li><li>Ensure clear communication, task delegation, and accountability across teams</li><li>Monitor productivity and assist in balancing workloads among team members</li></ul>Operations Growth Track<ul><li>Assist in improving systems, processes, and efficiencies</li><li>Monitor workflow and team performance</li><li>Coordinate between departments (tax, bookkeeping, client services)</li><li>Support implementation of tools, KPIs, and operational strategies</li><li>Gradually take ownership of firm operations and team oversight</li></ul>Qualifications<ul><li>2&ndash;5 years of experience as an Executive Assistant or Administrative Assistant</li><li>Strong organizational and multitasking abilities</li><li>Excellent written and verbal communication skills</li><li>Proven ability to coordinate across multiple teams, including remote staff</li><li>Proficiency in Microsoft Office, Google Workspace, and practice management tools</li><li>Self-starter with strong problem-solving skills</li><li>Interest in leadership, operations, and long-term career growth</li></ul>Preferred Qualifications<ul><li>Experience in a CPA firm or professional services environment</li><li>Familiarity with tax workflows and bookkeeping processes</li><li>Familiarity or experience with Karbon practice management software is a strong plus</li><li>Experience with CRM or workflow management systems</li></ul>Career Growth Opportunity This role provides a structured path to becoming an Operations Manager, with hands-on experience in team leadership, process improvement, and strategic operations.Compensation &amp; Benefits<ul><li>Competitive salary (based on experience)</li><li>Performance-based bonuses</li><li>Paid time off and holidays</li><li>Professional growth and leadership development</li></ul>How to Apply Please submit your resume along with a brief cover letter outlining your interest in growing into an Operations Manager role.Join Bharmal &amp; Associates, Inc. and be part of a firm with over three decades of excellence while building your future in leadership and operations.sho--<ul><li>Prior experience in executive administrative support or personal assistant roles is highly desirable; office experience is essential. This role offers an engaging environment where your organizational talents will directly contribute to our company's success while paving the way toward operational leadership!</li></ul>Pay: $25.00 - $30.00 per hourBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Professional development assistance</li><li>Vision insurance</li></ul>Work Location: In person

Executive Administrative Assistant (Growth Track to Operations Manager

Big Air USA

<div>
 
 
 Marketing &amp; Events Coordinator
 
 , Corporate Marketing | Big Air USA
 
 
 
 Full-Time,
 
 Hybrid (2 days/week in
 
 Irvine, CA)
 
 
 
 
 
 
 
 About Big Air USA
 
 
 
 Big Air USA is one of the fastest-growing family entertainment brands in the country, bringing indoor trampoline and adventure parks to communities nationwide. We're growing with purpose, and our corporate marketing team is ready to do the same!
 
 
 
 
 
 
 The Role
 
 
 
 We're looking for a creative, organized, and self-motivated
 
 Marketing &amp; Events Coordinator
 
 to join our corporate team. In this role, you'll wear two important hats: supporting the marketing lifecycle of new parks as they move through the development pipeline toward their grand opening, and serving as a resource and partner to our growing network of franchisees.
 
 
 
 
 
 You'll work directly with franchisees to help them execute local marketing effectively, providing guidance, materials, and support rooted in the Big Air brand.
 
 
 
 
 
 
 What You'll Do
 
 
 <ul>
 <li>
 Own marketing timelines and deliverables for parks in the pre-opening phase, from initial launch prep through grand opening execution
 </li>
 <li>
 Support franchisees in planning and executing their Local Park Marketing, including seasonal campaigns, LTO promotions, Toddler Time, Cosmic Nights, birthday party marketing, fundraisers, street team events, and more
 </li>
 <li>
 Respond to franchisee support tickets for creative and strategic needs, including guidance on social media, email, SMS, community outreach, paid advertising, and advising on best practices,
 </li>
 <li>
 Identify partnership and sponsorship opportunities to support franchisee goals (schools, libraries, youth sports organizations, local influencers, etc.)
 </li>
 <li>
 Track and report on marketing performance across new openings and franchisee campaigns
 </li>
 <li>
 Embrace AI-assisted workflows
 </li>
 </ul>
 
 
 
 
 
 What We're Looking For
 
 
 <ul>
 <li>
 2 years of marketing experience, ideally in a multi-location, franchise, or entertainment/hospitality environment
 </li>
 <li>
 Strong project management instincts
 </li>
 <li>
 Clear communicator who can build trust with franchisee partners and collaborate well internally
 </li>
 <li>
 Comfortable working independently and owning your work, while thriving in a collaborative team environment
 </li>
 <li>
 Enthusiastic about learning new tools
 </li>
 <li>
 Proficiency in standard marketing tools (email platforms, social media, Canva or similar, basic analytics)
 </li>
 <li>
 Bonus: experience supporting or working within a franchise system
 </li>
 </ul>
 
 
 
 
 
 Compensation &amp; Perks
 
 
 <ul>
 <li>
 
 Salary: $70,000 - $75,000
 
 to start, depending on experience
 
 (see note below)
 
 </li>
 <li>
 
 Flexible PTO
 
 , we trust you to manage your time and take what you need
 </li>
 <li>
 
 401(k)
 
 plan available
 </li>
 <li>
 Hybrid schedule: 3 days remote, 2 days in our Irvine, CA office
 </li>
 <li>
 A genuinely fun brand to work for (yes, you might get to jump on trampolines)
 </li>
 </ul>
 
 
 
 
 
 Big Air USA is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
 
 
</div>

Marketing & Events Coordinator

Kelly Science, Engineering, Technology & Telecom

<div>
 
 Kelly Science and Clinical FSP is currently seeking a
 
 Study Start Up Specialist
 
 for a long-term engagement in the US with one of our Global Medical Device clients in Irvine, California. This is a
 
 hybrid
 
 position on site
 
 Tuesday/Thursday and every other Friday.
 
 This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
 
 
 
 
 
 Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.
 
 
 
 
 
 
 DESCRIPTION
 
 
 
 
 
 <ul>
 <li>
 Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
 </li>
 <li>
 May serve as the primary contact for clinical trial sites (e.g. site management);
 </li>
 <li>
 Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
 </li>
 <li>
 Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
 </li>
 <li>
 Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;
 </li>
 <li>
 Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
 </li>
 <li>
 Interfaces and collaborates with Clinical Research Associates (CRAs);
 </li>
 <li>
 Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;
 </li>
 <li>
 Assists in clinical data review to prepare data for statistical analyses and publications;
 </li>
 <li>
 May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
 </li>
 <li>
 May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
 </li>
 <li>
 Assists in tracking assigned project budgets;
 </li>
 <li>
 May perform other duties assigned as needed;
 </li>
 <li>
 Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
 </li>
 <li>
 Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
 </li>
 <li>
 Should develop a strong understanding of the pipeline, product portfolio and business needs;
 </li>
 <li>
 Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.
 </li>
 </ul>
 
 
 
 
 
 EXPERIENCE AND EDUCATION
 
 
 
 
 
 Education
 
 
 
 <ul>
 <li>
 Minimum of a Bachelor&rsquo;s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
 </li>
 </ul>
 
 
 
 Experience
 
 
 
 <ul>
 <li>
 BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.
 </li>
 <li>
 Previous experience in clinical research or equivalent is desired.
 </li>
 <li>
 Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,&hellip;).
 </li>
 <li>
 Clinical/medical background is a plus.
 </li>
 <li>
 Medical device experience is a plus.
 </li>
 </ul>
 
 
 
 
 
 REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
 
 
 
 
 
 Functional and Technical Competencies:
 
 
 
 <ul>
 <li>
 Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
 </li>
 <li>
 Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
 </li>
 <li>
 Presentation and technical writing skills;
 </li>
 <li>
 Written and oral English communication skills.
 </li>
 </ul>
 
 
 
 
 
 
 
 
 
 Leadership Competencies:
 
 
 
 
 Leadership required in alignment with J&amp;J Leadership Imperatives:
 
 <ul>
 <li>
 
 Connect
 
 - Develop collaborative relationships with key internal and external stakeholders.
 </li>
 <li>
 
 Shape
 
 - Actively participate in departmental process improvement activities.
 </li>
 <li>
 
 Lead
 
 - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
 </li>
 <li>
 
 Deliver
 
 - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
 </li>
 </ul>
 
 
 
 
 
 TRAVEL REQUIREMENTS
 
 
 <ul>
 <li>
 Ability to travel approximately 20% depending on the phase of the program.
 </li>
 </ul>
 
 
 
 
 
 EXTERNAL INTERACTIONS
 
 
 <ul>
 <li>
 Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.
 </li>
 <li>
 May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.
 </li>
 </ul>
 
 
</div>

Study Start Up Specialist

Explore 66+ Project coordinator in Irvine this April. Find roles across top companies and apply now to boost your career.